<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20120414009463N64</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on promoting sexual health and fertility in women with endometriosis</public_title>
      <acronym>PBT</acronym>
      <scientific_title>Effect of education based on planned behavior Theory on the promotion of sexual &amp; reproductive health of women with endometriosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be performed by randomized block design of two treatments with quadruple blocks. The letter A is for the intervention group and the letter B is for the control group. Then we write all the permutation compounds, which are 6 different compounds, on 6 cards as follows:
1. AABB,
2. ABBA,
3. ABAB,
4. BAAB,
5. BABA,
6. BBAA,
Then we will choose a digit from numbers 1 to 6 by drawing. For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: The present intervention is based on the model of the theory of planned behavior, which is a suitable theory for changing behavior. This model is defined based on the four elements of knowledge, attitude, mental norms and perceived behavioral control, and in this study, educational content will be designed based on this element.                                                                                                                                                                                                Intervention group: In addition to routine actions, the intervention group will receive training sessions. These sessions are held online in person as much as possible and in severe cases of illness. 4 training sessions for 120-190 minutes per week will be performed for the participants for four weeks. The content of the sessions includes educational videos, posters, slides, Virtual and video conversations and online tests.                                                                                                         Training activities based on this model for women with endometriosis in the structures of the model of the theory of planned behavior will be summarized as follows:                                                                                 first session: Educational content of this session includes: History of endometriosis in Iran and the world, latest global and national statistics Related to endometriosis will be the importance of endometriosis, the definition of endometriosis, the causes of endometriosis, age groups at risk, and ways to prevent endometriosis. At the end of the session, after summarizing the topic, their questions will be answered.                                                                                                 Second session: The content of the training program of the second session including: the effect of endometriosis on vital body function, symptoms and clinical course of endometriosis, disease stages, diagnostic methods, referral time To the doctor and midwife before and after the diagnosis, what to do after the diagnosis of endometriosis, treatment of endometriosis, misconceptions about endometriosis and the importance of nutrition in patients.                                                                                                                     Third session: The content of the educational program of the third session includes: costs related to treatment and follow-up for communities, social, psychological and psychological damage to endometriosis, sexual health and its dimensions, reproductive health, fertility concerns, misconceptions about Pregnancy, the importance of improving sexual health, sexual function and reproductive health in patients, the importance of obtaining accurate information about endometriosis, using and transmitting this information to others to increase their awareness and knowledge to help improve sexual health And their fertility.                                                                                               fourth session: At the beginning of the fourth session, a review of the issues raised in the previous session will be done and the questions and ambiguities of the people will be answered. During this session, misconceptions about not being pregnant, positive and negative attitudes toward endometriosis, mental beliefs, knowledge and attitudes about the disease, motivation to follow influential people and mental norms will be examined in a group discussion. At the end, a summary of what has been taught during the previous sessions will be presented to the people and their questions will be answered. Intervention 2: Control group: The control group does not receive any intervention and receives routine care by the clinic.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Behboodi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran</address>
        <city>Trhran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4227</telephone>
        <email>Behboodi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niyosha Zandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6654 2398</telephone>
        <email>n-zandi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Women with endometriosis based on medical tests or medical diagnosis and clinical signs                                                                                                                                                          2- No history of participating in training or counseling classes                                                       3- Having Iranian nationality                                                                                                                                                                                                                                    4- Age between 15 to 45 years                                                                                                                                  5- Having the ability to read and write                                                                                                           6- Non-addiction (based on patient file information available at the center)                                                                                                                                                                                                                                                                                                                                                                                 7- Do not consume alcohol                                                                                                                                             8- No known chronic diseases                                                                                                                                  9- No chronic psychiatric disorders and known malignant diseases (self-reported)                                                                                                                                                                                                  10. Being married or living with a spouse                                                                                                                                                                                                                                                                     11- Ability to use the Internet and cyberspace if the intervention is done virtually</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1-Having genital or reproductive infections at the same time as endometriosis                                                                                                                                                                                       2- Having underlying diseases                                                                                                                                                   3- single                                                                                                                                                                                                                              4- Not being able to use cyberspace and smart phone</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present intervention is based on the model of the theory of planned behavior, which is a suitable theory for changing behavior. This model is defined based on the four elements of knowledge, attitude, mental norms and perceived behavioral control, and in this study, educational content will be designed based on this element.                                                                                                                                                                                                Intervention group: In addition to routine actions, the intervention group will receive training sessions. These sessions are held online in person as much as possible and in severe cases of illness. 4 training sessions for 120-190 minutes per week will be performed for the participants for four weeks. The content of the sessions includes educational videos, posters, slides, Virtual and video conversations and online tests.                                                                                                         Training activities based on this model for women with endometriosis in the structures of the model of the theory of planned behavior will be summarized as follows:                                                                                 first session: Educational content of this session includes: History of endometriosis in Iran and the world, latest global and national statistics Related to endometriosis will be the importance of endometriosis, the definition of endometriosis, the causes of endometriosis, age groups at risk, and ways to prevent endometriosis. At the end of the session, after summarizing the topic, their questions will be answered.                                                                                                 Second session: The content of the training program of the second session including: the effect of endometriosis on vital body function, symptoms and clinical course of endometriosis, disease stages, diagnostic methods, referral time To the doctor and midwife before and after the diagnosis, what to do after the diagnosis of endometriosis, treatment of endometriosis, misconceptions about endometriosis and the importance of nutrition in patients.                                                                                                                     Third session: The content of the educational program of the third session includes: costs related to treatment and follow-up for communities, social, psychological and psychological damage to endometriosis, sexual health and its dimensions, reproductive health, fertility concerns, misconceptions about Pregnancy, the importance of improving sexual health, sexual function and reproductive health in patients, the importance of obtaining accurate information about endometriosis, using and transmitting this information to others to increase their awareness and knowledge to help improve sexual health And their fertility.                                                                                               fourth session: At the beginning of the fourth session, a review of the issues raised in the previous session will be done and the questions and ambiguities of the people will be answered. During this session, misconceptions about not being pregnant, positive and negative attitudes toward endometriosis, mental beliefs, knowledge and attitudes about the disease, motivation to follow influential people and mental norms will be examined in a group discussion. At the end, a summary of what has been taught during the previous sessions will be presented to the people and their questions will be answered.</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention and receives routine care by the clinic</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual &amp; reproductive health. Timepoint: Before the study, 4 weeks after the intervention, eight weeks after the intervention. Method of measurement: Endometriosis Reproductive Health Specific Questionnaire(ESHQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-28</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Gods Ave, Keshavaz Blvd,  Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
